Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Atrial Fibrillation Recurrent, Pulsed Field Ablation, Radiofrequency Catheter Ablation
Conditions
Brief summary
Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. As of 2019, there were approximately 59.7 million patients with AF worldwide, including atrial flutter (AF). Atrial fibrillation can significantly increase the risks of stroke, thromboembolism and heart failure in patients, seriously affecting their quality of life. Catheter ablation is the main means for rhythm control in patients with atrial fibrillation. A large number of clinical studies have confirmed the effectiveness and safety of catheter ablation for atrial fibrillation. It is significantly superior to drug treatment in maintaining sinus rhythm and can significantly improve symptoms and quality of life. Pulsed electric field ablation (PFA) is a novel ablation method that utilizes pulsed electric fields as energy. It uses multiple short-duration and high-voltage electrical pulses to release ablation energy, selectively causing myocardial cells to rupture and die. However, it has no obvious damaging effect on blood vessels, nerves, and tissues around the heart, such as the lungs, esophagus, and phrenic nerve. This trial was designed based on the advantage of the characteristic that PFA does not damage the esophagus, confining the damage to the posterior half of the left atrium and the circumferential isthmus of the mitral valve. While improving the ablation success rate, it is possible to protect the function of the left atrium. This study aims to verify the superiority of the new rhythm control strategy in a large-scale population by launching a prospective randomized controlled trial.
Interventions
PROCEDUREPulsed field ablation
Left atrial electrical anatomical mapping modeling was performed using a high-density mapping catheter, and ablation was carried out using a pulsed field catheter. For patients with paroxysmal atrial fibrillation, bilateral large loop pulmonary vein isolation combined with left posterior atrial wall ablation is performed. For patients with persistent atrial fibrillation, bilateral large loop pulmonary vein isolation, left posterior atrial wall ablation, and mitral valve isthmus ablation are performed. For patients with atrial fibrillation rhythm after ablation, intravenous ibutilide/electrical cardioversion was used for conversion, and the specific conversion strategy was consistent with that of the radiofrequency ablation group.
PROCEDURERadiofrequency ablation alone
Radiofrequency ablation will be performed using a saline perfusion catheter, and the ablation catheter was empirically selected by the surgeon. For patients with paroxysmal atrial fibrillation, circumferential pulmonary vein isolation is performed. For patients with persistent atrial fibrillation, circumferential pulmonary vein isolation combined with individualized linear ablation is performed. For those whose ablation of all the established routes has been completed but whose sinus rhythm has not been restored, intravenous ibulide is used for drug cardioversion. If the drug fails to counteract, perform two-phase alternating current cardioversion. Cardioversion can be repeated at most twice.
Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Atrial fibrillation patients who will accept catheter ablation. 2. Age ≥ 18. 3. Be capable of understanding and signing the informed consent form.
Exclusion criteria
1. Have contraindications for catheter ablation (such as atrial thrombosis, decompensated heart failure, etc.) 2. Have accepted catheter ablation before. 3. Myocardial infarction, or any cardiac interventional/surgery has been performed within 3 months. 4. Had a stroke or transient ischemic attack within 6 months. 5. Allergy to iodine contrast agents. 6. Participate in clinical trials related to other drugs or devices. 7. Pregnant women, lactating women, or women with plans to become pregnant shortly. 8. Active stage of infection. 9. Secondary atrial fibrillation, such as combined with rheumatic heart disease, hypertrophic cardiomyopathy, etc. 10. Patients who do not agree to be enrolled or are unable to cooperate to complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial fibrillation within 12 months after ablation | 12 months after ablation | Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after the post-ablation blanking period, documented by 12-lead electrocardiogram, Holter monitoring, event recorder, or other rhythm monitoring methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in atrial fibrillation burden from baseline to 12 months after ablation | Baseline and 12 months after ablation | Change in atrial fibrillation burden among participants with paroxysmal atrial fibrillation. Atrial fibrillation burden is defined as the percentage of monitored time spent in atrial fibrillation during rhythm monitoring. |
| Change in left ventricular ejection fraction from baseline to 12 months after ablation | Baseline and 12 months after ablation | Change in left ventricular ejection fraction measured by echocardiography. Unit of Measure: Percentage points |
| Change in 36-Item Short Form Health Survey physical component summary score from baseline to 12 months after ablation | Baseline and 12 months after ablation | Change in quality of life assessed using the physical component summary score of the 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better physical health status. |
| All-cause mortality within 12 months after ablation | 12 months after ablation | Death from any cause during the 12-month follow-up period after ablation. Unit of Measure: Number or percentage of participants |
| Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation | Baseline and 12 months after ablation | Change in quality of life assessed using the mental component summary score of the 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better mental health status. |
Countries
China
Contacts
CONTACTYan Yao
Outcome results
None listed